Gut MicrobiomeNCT05615961
Effect of Probiotics on Endurance Athletes' Microbiome at Rest and Post-race
A study testing Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK) in people with Gut Microbiome and Gut Microbiota, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
This study is intended to investigate the use of probiotics (LAB4 probiotics, Cultech, Port Talbot, Wales, UK) and the effect this has on gastrointestinal symptoms experienced during elite long-distance triathlon (ironman) competition, as well as the composition of the gut bacteria in the athlete. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Gut Microbiota, Aerobic Exercise
- What is being tested?
- Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2022to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-85
- Qualification for the Kona Ironman World-championships in Hawaii
Who cannot join
- Have a current musculoskeletal injury.
- Currently unwell with cold or flu
- Have been told they have liver disease
- Have gastric Ulcer or other gastric/stomach problems
- Have a condition/disease of the Gut/bowel.
- Have diagnosed uncontrolled asthma
Show all 10Show fewer
- Have kidney problems
- Have a chronic connective tissue disorder
- Have suffered cerebrovascular disease such as a stroke
- Are taking balcofen, methotrexate, tacrolimus and voriconazole, beta-blockers or diuretics drugs
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L3 3AF
About this study
This study is intended to investigate the use of probiotics (LAB4 probiotics, Cultech, Port Talbot, Wales, UK) and the effect this has on gastrointestinal symptoms experienced during elite long-distance triathlon (ironman) competition, as well as the composition of the gut bacteria in the athlete.
Long-distance triathlon events frequently induce gastrointestinal discomfort due to the duration of the event (8-17 hours), the intensity of the exercise and the ingestion of large amounts of sugars throughout the event.
Read more
Data will be collected from athletes participating at the Kona ironman World-championships. Participants will supplement with either probiotic tablet, or placebo (sugar-pill) for 4-weeks prior to competition.
Athletes will be both male and female age-group athletes from any qualifying age category (age categories are as follows: 18-24; 25-29; 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69; 70-74; 75-79; 80-84).
The main investigation of the study will be the occurence/frequency/severity of gastrointestinal symptoms during training and competition between groups.
Read the detailed description
The study will recruit ironman triathletes who have qualified for the Kona ironman World-championships in Hawaii. Participants will be allocated into either probiotic (Lab4 Probiotics, Cultech, Port Talbot, Wales, UK) or placebo (Maltodextrin) groups, in a double-blind fashion (Blinded by supplement supplier).
Those recruited into the study will have their training load and gut symptoms monitored for 8-weeks prior to competition via the completion of online questionnaires (previously validated).
Four-weeks prior to competition participants will provide a stool sample for microbiome analysis, they will then proceed to supplement with probiotic or placebo for 4-weeks. 24-h prior to competition they will provide a stool sample as well as providing a sample from the first bowel movement post-race, which will be used for microbiome analysis.
Data will be collected for pre-race and raceday nutrition, as well as outcome measures for raceday performance and gastroitestinal symptoms experienced, again via online questionnaire.
Stool samples will be analysed by an independent laboratory that specialises in microbiome analysis.
Primary outcome measures will be the composition of the gut bacteria and the metabolites (substances produced) of the gut bacteria at baseline, pre-race and post-race. As well as the occurrence (frequency, duration, severity) of gastrointestinal symptoms during training and competition.
- Conditions
- Gut Microbiome, Gut Microbiota, Aerobic Exercise, Gastrointestinal Tract Irritation, Athletes, Probiotics
- Being tested
- Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK), Placebo
- Keywords
- Probiotics, Endurance Exercise, Triathlon, GI Disturbance, Gut Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK)Dietary supplement
Also called Lab4 Probiotics, Cultech, Port Talbot, Wales, UK
The intervention is a unique blend of probiotic cultures from a well-established manufacturer.
PlaceboDietary supplement
Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Supplementation Arm | Experimental | This group will receive the probiotic supplement for 4-weeks prior to their ironman race performance. Receives: Dietary Supplement: Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK) |
| Placebo Arm | Placebo comparator | This group will receive the placebo capsules for 4-weeks prior to their ironman race performance. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the gut microbiome
This will assess the bacterial content in the gut of the participants, performed using shotgun metagenomic sequencing
Measured: 4-weeks
Gastrointestinal symptoms during training and competition
This will be the subjective assessment of any gastrointestinal symptoms experienced during training and competition, from a previously validated questionnaire
Measured: 8-weeks
Secondary outcomes (3)
Training volume and intensity
This will be a quantification of the amount of training completed in the 8 weeks leading up to the race, via questionnaire.
Measured: 8-weeks
Perceived stress
This will be the subjective assessment of how stressed participants are in the 8 weeks leading up to competition, via questionnaire.
Measured: 8-weeks
Quality of sleep
This will be a subjective assessment of how well-rested the participants are in the 8 weeks leading up to competition, via questionnaire.
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Jul 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned into either supplement or placebo intervention groups, in a pair-matched, double-blind, placebo controlled manner.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Southern University, University of Illinois Chicago
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615961
- Sponsor's protocol ID
- 021/SPS/051
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Endurance Athletes' Microbiome at Rest and Post-race
- ClinicalTrials.gov ID
- NCT05615961
- Acronym / sponsor ID
- 021/SPS/051
- Conditions
- Gut Microbiome, Gut Microbiota, Aerobic Exercise, Gastrointestinal Tract Irritation, Athletes, Probiotics
- Keywords
- Probiotics, Endurance Exercise, Triathlon, GI Disturbance, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Georgia Southern University, University of Illinois Chicago
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to investigate the use of probiotics (LAB4 probiotics, Cultech, Port Talbot, Wales, UK) and the effect this has on gastrointestinal symptoms experienced during elite long-distance triathlon (ironman) competition, as well as the composition of the gut bacteria in the athlete.
Long-distance triathlon events frequently induce gastrointestinal discomfort due to the duration of the event (8-17 hours), the intensity of the exercise and the ingestion of large amounts of sugars throughout the event.
Data will be collected from athletes participating at the Kona ironman World-championships. Participants will supplement with either probiotic tablet, or placebo (sugar-pill) for 4-weeks prior to competition.
Athletes will be both male and female age-group athletes from any qualifying age category (age categories are as follows: 18-24; 25-29; 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69; 70-74; 75-79; 80-84).
The main investigation of the study will be the occurence/frequency/severity of gastrointestinal symptoms during training and competition between groups.
Detailed description
The study will recruit ironman triathletes who have qualified for the Kona ironman World-championships in Hawaii. Participants will be allocated into either probiotic (Lab4 Probiotics, Cultech, Port Talbot, Wales, UK) or placebo (Maltodextrin) groups, in a double-blind fashion (Blinded by supplement supplier).
Those recruited into the study will have their training load and gut symptoms monitored for 8-weeks prior to competition via the completion of online questionnaires (previously validated).
Four-weeks prior to competition participants will provide a stool sample for microbiome analysis, they will then proceed to supplement with probiotic or placebo for 4-weeks. 24-h prior to competition they will provide a stool sample as well as providing a sample from the first bowel movement post-race, which will be used for microbiome analysis.
Data will be collected for pre-race and raceday nutrition, as well as outcome measures for raceday performance and gastroitestinal symptoms experienced, again via online questionnaire.
Stool samples will be analysed by an independent laboratory that specialises in microbiome analysis.
Primary outcome measures will be the composition of the gut bacteria and the metabolites (substances produced) of the gut bacteria at baseline, pre-race and post-race. As well as the occurrence (frequency, duration, severity) of gastrointestinal symptoms during training and competition.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned into either supplement or placebo intervention groups, in a pair-matched, double-blind, placebo controlled manner.
| Arm | Type | Receives |
|---|---|---|
| Probiotic Supplementation Arm | Experimental | Dietary Supplement: Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK)This group will receive the probiotic supplement for 4-weeks prior to their ironman race performance. |
| Placebo Arm | Placebo comparator | Dietary Supplement: PlaceboThis group will receive the placebo capsules for 4-weeks prior to their ironman race performance. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18-85
- Qualification for the Kona Ironman World-championships in Hawaii
Key exclusion criteria (10 listed)
- Have a current musculoskeletal injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK)Also: Lab4 Probiotics, Cultech, Port Talbot, Wales, UKThe intervention is a unique blend of probiotic cultures from a well-established manufacturer. | Dietary supplement | Probiotic Supplementation Arm |
| PlaceboPlacebo Tablets | Dietary supplement | Placebo Arm |
Primary outcome
Composition of the gut microbiome
Time frame: 4-weeks
This will assess the bacterial content in the gut of the participants, performed using shotgun metagenomic sequencing
Gastrointestinal symptoms during training and competition
Time frame: 8-weeks
This will be the subjective assessment of any gastrointestinal symptoms experienced during training and competition, from a previously validated questionnaire
3 secondary outcomes
Training volume and intensity
Time frame: 8-weeks
Perceived stress
Time frame: 8-weeks
Quality of sleep
Time frame: 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK) in people with Gut Microbiome and Gut Microbiota, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of the gut microbiome (time frame: 4-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.